Russian clinical trial approvals climb 38% in Q2

Russia’s Federal Service for the Supervision of Health and Social Development, Roszdravnadzor (RZN), approved a total of 178 new clinical trials, including bioequivalence studies, in the second quarter of 2010 – 38.0% more than in the same period last year.

Although the largest proportion of these trials – 43.3% – were multinational, multicentre studies with Russian arms, in the second quarter of 2009 they represented 64.3% of the 129 multinational trials approved in Russia during that period. The volume of multinational studies declined by 7.2% to 77 between Q2 2009 and Q2 2010.

There was a significant increase (+151.9%) during the latest quarter in the number of local trials started in Russia by domestic or foreign sponsors, which rose from 27 to 68. RZN approved 33 bioequivalence studies during the second quarter, 73.7% more than in the same period last year.

Broken down by sponsor, there was also a marked shift from multinational to local. International sponsors accounted for 51% of all clinical trials cleared by RZN, compared with 67% in Q2 2009, while the share of Russian sponsors widened from 33% to 49%.

Country by country, Russian sponsors took the highest share of clinical trial starts during the latest quarter, with a total of 87 studies approved, followed by the US (20 studies), Germany (16), Switzerland (10) and the UK (7).

Phase III trials dominated the Russian approval landscape in the second quarter of 2010 with 83 studies in total, making up 59.7% of all Phase I-IV trials cleared by RZN during that period. The number of Phase III trials was 29.7% higher than in the second quarter of 2009.

Next came Phase II trials, flat against Q2 2009 with 29 studies approved and 20.9% of the total, then 14 Phase IV trials (+40%) and 13 Phase I trials (+85.7%).

The top five international sponsors of clinical trials approved in Russia during the second quarter of 2010 were Novartis (11 studies), GlaxoSmithKline (6), Johnson & Johnson (5), Teva (4) and Novo Nordisk (4).

The top five Russian sponsors were Rafarma (4), Materia Medica, Biocad and Nizhpharm (three trials apiece), then Firn N (2).